Occlutech announces Completion of Patient Enrolment in Pilot Study of Atrial Flow Regulator (AFR) in Patients with Heart Failure
PR88231
SCHAFFHAUSEN, Switzerland, February 24, 2021, /PRNewswire=KYODO JBN/--
Occlutech, a privately-held company, announced today the completion of patient
enrolment in its pilot study to assess safety and efficacy of the novel Atrial
Flow Regulator (AFR) in heart failure (HF) patients (PRELIEVE trial).
PRELIEVE is a prospective, multicenter, open-label, non-randomized pilot study
that evaluates the results of AFR implantation in patients with either heart
failure with preserved ejection fraction (HFpEF) or heart failure with reduced
ejection fraction (HFrEF).
HF affects millions of people around the globe and has a big impact on
mortality and healthcare expenditure. Even with the best medical therapy, many
patients experience persistent symptoms and low quality of life as a result of
elevated left atrial pressure.
AFR is a minimally invasive cardiac implant that is designed to maintain a
permanent interatrial communication and allows controlled blood flow from
overloaded left atrium to the lower pressure right atrium.
"The completion of the enrolment is another important milestone for Occlutech
and we are excited to support this therapy option for heart failure patients
with our clinical activities." says Sabine Bois, CEO Occlutech Group.
Occlutech is one of the leading companies in its field, with several major
products including state-of-the-art PFO occluders, ASD occluders among others.
Occlutech has sales of congenital and structural heart products in over 80
countries and maintains manufacturing and R&D facilities in Jena, Germany and
Istanbul, Turkey. Occlutech has developed many novel products and technologies
to improve treatment of patients in these and related areas.
For additional information about the Company's products, the Occlutech AFR, or
to inquire about participation in our patient registries, please visit
Occlutech´s website at www.occlutech.com or contact us directly at
AFR@occlutech.com
The AFR is not approved in the United States. Product availability is subject
to local regulatory clearance. The AFR is under clinical investigation for use
in patients with pulmonary arterial hypertension and use in these patients is
limited by applicable national laws.
Contact:
Sabine Bois
CEO Occlutech Group
Mobile: +49 160 90792130
Email: sabine.bois@occlutech.com
SOURCE: Occlutech International
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